Gestational Diabetes and Health Outcomes in Mothers and Babies

Condition(s) studied

Study summary

Gestational diabetes mellitus (GDM) is a common pregnancy complication characterized by impaired glucose metabolism and increased insulin resistance. GDM is associated with adverse pregnancy outcomes and an increased long-term risk of metabolic and cardiovascular disease for both mother and offspring.

This prospective observational cohort study aims to establish a longitudinal pregnancy and birth cohort of women diagnosed with GDM. Pregnant women with a positive 75 g oral glucose tolerance test (OGTT) between gestational weeks 24 and 28 will be recruited after diagnosis and followed through late pregnancy, delivery, and early postpartum.

Participants will undergo two study visits during pregnancy, sample collection at delivery, and one postpartum visit 8-12 weeks after birth. Clinical data, physical measurements, questionnaire-based information, and biological samples will be collected from mothers and infants to enable comprehensive phenotyping of GDM pregnancies.

Data and biosamples from this cohort will be used for descriptive and hypothesis-driven analyses and may be compared with data from an existing longitudinal cohort of healthy pregnancies to support interpretation of GDM-related changes.

Eligibility

Primary outcome measure(s)

• Maternal metabolic and cardiometabolic phenotype: Adiposity — From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
  Measured as fat mass and fat-free mass by air displacement plethysmography longitudinally after gestational diabetes diagnosis and during early postpartum follow-up.
• Maternal metabolic and cardiometabolic phenotype: fasting glucose — From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
  Fasting blood glucose as measured in mg/mL from NaF blood tubes longitudinally after gestational diabetes diagnosis and during early postpartum follow-up.
• Maternal metabolic and cardiometabolic phenotype: blood pressure — From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
  Resting systolic and diastolic blood pressure measured using standardized clinical procedures after gestational diabetes diagnosis and during early postpartum follow-up.
• Maternal metabolic and cardiometabolic phenotype: cytokine profile — From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
  Serum cytokine will be analysed by multiplexing after gestational diabetes diagnosis and during early postpartum follow-up.
• Maternal metabolic and cardiometabolic phenotype: lipid profile (triglycerides, phospholipids, free, fatty acids, HDL/LDL/total cholesterol) — From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
  Lipid profiles are measured after gestational diabetes diagnosis and during early postpartum follow-up.
• Maternal metabolic and cardiometabolic phenotype: endothelial function — From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
  Endothelial function measured as pulse wave velocity using a Vicorder® after gestational diabetes diagnosis and during early postpartum follow-up.
• Infant outcomes: adiposity — At birth and at 8-12 weeks postpartum.
  Measured as fat mass and fat-free mass by air displacement plethysmography (via PEAPOD)
• Infant outcomes: Neonatal C-peptide in cord blood — At birth
  Concentrations of C-peptide in cord blood serum
• Infant outcomes: Neonatal glucose in cord blood — At birth
  Concentrations of glucose in cord blood serum

Trial sites (1)

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